This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

About Us: Baxter’s Mission:

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. 

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics, and in the home. For over 90 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful, and inspire each other. This is where you can do your best work. 

Join us at the intersection of saving and sustaining live, where your purpose accelerates our mission. 

Your role at Baxter:

This is where we want to count on your talent to develop, coordinate and manage overall engineering resources and programs to ensure full compliance with corporate, ISO and FDA regulations. 

You”ll drive process improvement and monitor product performance by identifying and supporting key related projects and data trends through monthly indicators and quality trends / Management review meetings.

Your talent and experience will be a key factor in the manufacturing, validation and CAPA process, providing statistical technical support to ensure process control. You”ll be our CAPA, NCR and complaint (SME) expert to manage the overall plant effort, regulatory programs and standards requirements to ensure full compliance to implement on site in a timely manner.

Your team:

We develop quality products with the patient in mind, so our efforts are also patient-centric. That means you can be proud of our work and the value we provide to people every day. As a large, multinational organization, you have the opportunity to expand your knowledge through collaboration with a variety of individuals, exposure to different facets of our portfolio, and a supportive leadership team that encourages ongoing development.

The quality team is distinguished by its results-oriented approach, always striving to fulfill our mission to save & sustain lives.

What you’ll be doing:

• Manage engineering resources to set workload priorities in areas of responsibilities as established by management.  
• Assure good documentation practice (GDP) and good manufacturing practice (GMP) principles are used, that all elements of the complaints processes are clearly documented in each file and corporate complaints process objectives are met.
• Analyzed complaints, CAPA and NCR indicators and submit them to management for review in the corresponding quality boards.
• Identify complaints stages and pending commitments in order to assure compliance with deadlines and if applicable, identify situations on time.
• Initiates or recommends special studies and analyses of new products or processes to evaluate quality and reliability.
• Develop and evaluate quality sampling plans techniques for further improvement.
• Develops and manages VIP objectives and monitors implementation results.
• Assure quarterly quality system management reviews are in order to identify areas for opportunities, both for productivity and quality improvements, supporting our facility quality improvement process.
• Evaluates and assures product’s quality through quality indicators and keeps product release performance within standards.
• Supports FDA and third-party inspections.

What you’ll bring:

• Bachelor’s degree in science (B.S.), pharmacy, industrial engineering or related field.
• At least eight (8) years of experience in quality.
• American society for quality (ASQ) certified quality engineer (CQE) or green belt certification (preferred).  
• Experience in validation processes, manufacturing process of medical devices and implementation of projects.
• Must be knowledgeable of specifications, procedures and regulatory requirements (Ex. GMP, DHSS, OSHA, ISO, etc.) 
• Knowledge of medical device regulations.
• Knowledge and application in computer system, 21 CFR Part 11, OSHA, GMP, general FDA regulations, good documentation practices, CAPA, internal audit and training.
• Process and product validation/design.
• Knowledge of ISO 13485 requirements.
• Statistical techniques, process control tools and acceptance sampling knowledge.
• Fully bilingual, english & spanish.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.